Recent positive decisions on patenting and EU funding of human embryonic stem cell (hESC) research herald a more positive New Year for regenerative medicine, but policy makers must ensure that Horizon 2020 provides the support the industry needs to capitalise on this and move therapies forward.
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Experts debate the future of stem cellsEurope is currently a world leader in the fundamental science underpinning regenerative medicine and cell therapy, and in its therapeutic use and regulation. But how can Europe build on its leading position?
“There is still a degree of uncertainty, but the clarification on [patents] and the preliminary agreement on maintaining the status quo for financing [hESC] research means things are going in the right direction,” said Magda Chlebus, Director of Science Policy at the European Federation of Pharmaceutical Industries and Associations told participants at a webinar held to launch the Science|Business report, ‘Regenerate the Future: How Europe can build on its leading position in regenerative medicines and stem cells.’
Now however, as negotiations come to a head, there is a risk that the number of proposed amendments to Horizon 2020, the EU’s 2014 – 2020 research programme, could destroy the structure set out by the European Commission, Chlebus believes.
This threatens to undermine two key ambitions embodied in Horizon 2020, of applying regenerative medicine to improve healthcare, whilst at the same time using it as a tool of industrial policy to maintain and attract companies with high growth potential. “The EU framework for research and science in Horizon 2020 aims to combine these two in one policy – to achieve healthcare goals and create a better economic [environment],” Chlebus noted.
Given the number of proposed amendments “there will have to be a lot of discussion in order not to completely destroy the Horizon 2020 structure proposed by the Commission,” Chlebus said.
Bumps and Hurdles
Ruth McKernan, Chief Scientific Officer of Neusentis, the regenerative medicine arm of Pfizer, agreed that support is needed to enable academics, SMEs, clinicians, venture capitalists and pharma companies to work together and make regenerative medicine a reality. This is a long-term project, and there will be many bumps and hurdles in the road. It takes many years to develop a conventional drug and there is no reason why developing a cell therapy can be any quicker. “It’s a ten year commitment,” McKernan said.
Similarly, Katherine Littler, Policy Adviser at the Wellcome Trust, said the fundamental requirement now is to support collaboration - both across Europe and with the rest of the world. “What happens in Europe is relevant all over the world. Any negative messages about funding and the regulatory environment could harm the freedom of researchers and can have a massive impact financially, as it deters investors.”
Despite the recent positive developments on patenting and EU funding there remain concerns about the regulatory environment, Littler told the webinar. “To foster research in regenerative medicine we need a level of clarity.” However, the sands are shifting constantly. “We need clarity; it’s difficult to operate if things keep changing,” Littler said.
Harmonising regulation
To achieve this, there should be a move to streamline and harmonise EU and national legislation. “Uphold subsidiarity but harmonise across Europe so we can conduct research projects across Europe,” Littler suggested.
Theo Meert, Senior Director External Innovation in Neurosciences, Janssen Pharmaceutica agreed harmonised regulations are needed to advance regenerative medicine. In particular, there is a need to share materials, tissue samples and information relating to the medical history of patients, both across Europe and between SMEs and bigger companies. “It’s extremely important that this research can be done on a large scale and at a pre-competitive level,” Meert said.
Currently, the EU is more advanced than the US or Asia Pacific in supporting large-scale pre-competitive research, and Horizon 2020 must maintain this, allowing pharma, SMEs and academics to work together to avoid duplication and bringing together people in different parts of the ecosystem.
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